Lapatinib With Temozolomide and Regional Radiation Therapy for Patients With Newly-Diagnosed Glioblastoma Multiforme

PHASE2CompletedINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

December 7, 2012

Primary Completion Date

May 7, 2024

Study Completion Date

May 7, 2024

Conditions
Newly Diagnosed Glioblastoma Multiforme
Interventions
OTHER

Lapatinib/Temozolomide/radiation

Patients will be treated with a pulse dose of lapatinib every week and temozolomide 75 mg/m2 daily during radiation. Lapatinib will be administered beginning on the first day of radiation and temozolomide (+/-2 days). External beam fractionated regional radiation will be given on consecutive week days at 200 cGy daily doses to a total dose of 6000 cGy. Patients will have rest from temozolomide only for 2-4 weeks. Patients will continue with weekly pulse-dosing of lapatinib. After a 2-4 weeks rest(for temozolomide only) following completion of radiation therapy, temozolomide will be restarted as Cycle 1 at 150 mg/m2/day for 5 days out of every 28.Subsequent cycles can increase to 200 mg/m2/day as tolerated per investigator's judgment. Lapatinib pulse doses will be continued every week without interruption.Treatment will continue for 24 additional 28-day cycles of temozolomide if there is no evidence of progression.

Trial Locations (1)

90095

UCLA, Los Angeles

Sponsors

Collaborators (2)

All Listed Sponsors
collaborator

GlaxoSmithKline

INDUSTRY

collaborator

Novartis

INDUSTRY

lead

Jonsson Comprehensive Cancer Center

OTHER